Leniolisib

What is Leniolisib?

• Leniolisib (Joenja) is a kinase inhibitor.

Leniolisib

What are the uses of this medicine?

• Leniolisib (Joenja) is used for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.

How does this medicine work?

• Leniolisib inhibits PI3K-delta by blocking the active binding site of PI3K-delta.
• In cell-free isolated enzyme assays, leniolisib was selective for PI3K-delta over PI3K-alpha, PI3K-beta, and PI3K-gamma, as well as the broader kinome.
• In cell-based assays, leniolisib reduced pAKT pathway activity and inhibited proliferation and activation of B and T cell subsets.
• Gain-of-function variants in the gene encoding the p110-delta catalytic subunit or loss of function variants in the gene encoding the p85-alpha regulatory subunit each cause hyperactivity of PI3K-delta.
• Leniolisib inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Be sure to mention any of the following:

• St. John's Wort
• Strong CYP3A4 Inhibitors
• Strong and Moderate CYP3A4 Inducers
• CYP1A2 Metabolized Drugs with a Narrow Therapeutic Index (NTIs)
• BCRP, OATP1B1, and OATP1B3 Substrates

Is this medicine FDA approved?

• Leniolisib was approved for medical use in the United States in March 2023.
• It is the first approved drug for this indication.

How should this medicine be used?

• Verify pregnancy status in females of reproductive potential prior to initiating treatment.

Recommended dosage:

• The recommended dosage of Joenja in adult and pediatric patients 12 years of age and older weighing 45 kg or greater is 70 mg administered orally twice daily approximately 12 hours apart, with or without food.
• There is no recommended dosage for patients weighing less than 45 kg.

• If you vomit with 1 hour after you take leniolisib, take another dose as soon as possible. If you vomit more than 1 hour after you take leniolisib, do not take another dose. Continue your regular dosing schedule.
• Advise patients that if a dose is missed by more than 6 hours, wait and take the next dose at the usual time.

Administration:

• Leniolisib comes as a tablet to take by mouth.
• It is usually taken with or without food twice a day, about 12 hours apart.
• Take leniolisib at around the same times every day.
• Take leniolisib exactly as directed.
• Do not take more or less of it or take it more often than prescribed by your doctor.
• If you vomit with 1 hour after you take leniolisib, take another dose as soon as possible.
• If you vomit more than 1 hour after you take leniolisib, do not take another dose.
• Continue your regular dosing schedule.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 70 mg leniolisib

This medicine is available in fallowing brand namesː

• Joenja

What side effects can this medication cause?

The most common side effects of this medicine include:

• Headache
• Sinusitis
• Dermatitis atopic
• Tachycardia
• Diarrhea
• Fatigue
• Pyrexia
• Back pain
• Neck pain
• Alopecia

What special precautions should I follow?

• Based on findings in animals, Joenja may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use highly effective methods of contraception during treatment and for 1 week after the last dose.
• Advise women not to breastfeed during treatment with Joenja and for 1 week after the last dose.
• Live, attenuated vaccinations may be less effective if administered during Joenja treatment.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• If overdosage occurs, monitor the patient for any signs or symptoms of adverse reactions.
• Treatment of overdose with Joenja consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.

Can this medicine be used in pregnancy?

• Joenja can cause fetal harm based on findings from animal studies.
• There are no available data on Joenja use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
• Verify the pregnancy status in females of reproductive potential prior to initiating Joenja.
• Advise female patients of reproductive potential to use highly effective contraception during treatment with Joenja and to continue contraception for 1 week after the last dose.

Can this medicine be used in children?

• The safety and effectiveness of Joenja have not been established in pediatric patients below the age of 12 years.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Leniolisib phosphate

Inactive ingredients:

• colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

• The tablet film-coating contains hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, polyethylene glycol, talc, and titanium dioxide.

Who manufactures and distributes this medicine?

Manufactured by:

• Skyepharma Production SAS, ZI Chesnes Ouest, 55, Rue du Montmurier, Saint Quentin Fallavier, France for Pharming Technologies B.V.
• Joenja is a trademark of Pharming Intellectual Property B.V.

What should I know about storage and disposal of this medication?

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
• Do not refrigerate.
• Store and dispense in original container.

• Dailymed label info on Leniolisib
• FDA Leniolisib

Leniolisib Resources
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